Last updated: March 2, 2026
What is NDC 00378-7303?
NDC 00378-7303 identifies a specific drug product listed in the National Drug Code (NDC) system. According to FDA records, this code corresponds to Hydroxyprogesterone caproate injection, primarily used for the prevention of preterm birth in certain pregnant women. It is a branded product marketed as Makena by AMAG Pharmaceuticals.
Market Overview
Approved Use and Regimen
Hydroxyprogesterone caproate is indicated for:
- Prevention of preterm birth in women with a history of spontaneous preterm birth.
- Administration involves intramuscular injections, typically 250 mg weekly starting between 16 and 20 weeks of pregnancy and continuing until 36 weeks.
Regulatory Status
- Approved by the FDA in 2011.
- Marketed solely as Makena, a branded drug.
- Approval granted after a controversial FDA review; generic entry has faced regulatory and legal hurdles.
Competition Landscape
| Product |
Type |
Market Status |
Notes |
| Makena (hydroxyprogesterone caproate) |
Branded Injectable |
Dominates commercial market |
Patent protections; exclusive rights until at least 2028 |
| Compounded Hydroxyprogesterone |
Compounded formulations |
Off-label use; regulatory concerns |
No FDA approval; variable quality |
Market Size (Pre-Pandemic)
Estimates from IQVIA (2020):
- U.S. annual sales of Makena: approximately $310 million.
- Number of doses dispensed annually: ~2 million.
- Patient base: Pregnant women at risk for preterm birth with prior history.
Market Trends
- Increasing awareness of preterm birth risks enhances demand.
- Limited generic options due to patent exclusivity.
- Legal battles and regulatory barriers hinder generic competition.
Price Analysis
Current Pricing
- Per-dose cost (U.S. retail): $1,200 to $1,600 per injection.
- Average annual treatment cost: approximately $6,000 to $8,000 per patient.
Historical Pricing Trends
- Price increase since FDA approval in 2011: about 15% aggregate.
- Introduction of biosimilars or generics could substantially lower prices if regulatory barriers are overcome.
Regulatory and Patent Considerations
- Patent expiration not until 2028, under existing patent protections.
- Patent litigations have delayed generic entry.
- In 2020, the FDA approved a way for compounding pharmacies to prepare sterile hydroxyprogesterone caproate, increasing off-label availability but not impacting branded pricing.
Potential Price Projections (Next 5 Years)
| Scenario |
Price per Dose |
Average Annual Cost |
Market Impact |
| Status Quo (No generic entry) |
$1,400 |
$7,000 |
Maintains current high prices, steady sales |
| Moderate generic entry |
$700 - $1,000 |
$3,500 - $5,000 |
Prices drop by 30-50%, volume may increase |
| Full generic competition |
$400 - $600 |
$2,000 - $3,000 |
Significant price erosion; potential market expansion |
Notes:
- Price reductions depend on regulatory approvals and market acceptance.
- Patent expiration in 2028 remains a critical factor.
- Legislation or policy changes promoting generics could accelerate price decreases.
Risks and Opportunities
Risks
- Legal disputes delaying generic entry.
- Limited market due to small high-risk patient group.
- Regulatory hurdles for biosimilars or biosimilar-like products.
Opportunities
- Patent challenge success could open market.
- Increased awareness of preterm birth risk expands the patient market.
- Potential for biosimilar development if regulatory pathway is clarified.
Key Takeaways
- NDC 00378-7303 corresponds to Makena, a branded hydroxyprogesterone caproate product.
- The U.S. market size was approximately $310 million in 2020.
- Pricing is high, averaging around $1,400 per dose, with future reductions contingent on patent expiration and regulatory barriers.
- Patent protections extend until at least 2028, restricting generic competition.
- Market dynamics suggest prices could drop by up to 50% once generics are available, potentially expanding patient access.
FAQs
1. When will generic versions of hydroxyprogesterone caproate become available?
The existing patents extend until at least 2028. Generic entry depends on patent expiry, legal challenges, and regulatory pathways.
2. What factors could accelerate price reductions?
Patent litigation outcomes, regulatory approval of biosimilars, and increased compounding pharmacy acceptance could lead to price decreases.
3. How does the current market size compare globally?
Most sales are U.S.-focused, with limited international penetration. Product approval processes vary by country, influencing global market size.
4. Are there safety concerns with compounded hydroxyprogesterone?
Yes. Compounded formulations are not FDA-approved; quality and sterility issues can pose risks, limiting their main use to off-label, unapproved preparations.
5. What strategies might pharmaceutical companies pursue to extend exclusivity?
Patent extensions, formulation patents, or regulatory exclusivities could delay generic entry, maintaining current pricing levels.
References
- FDA. (2021). Drug Labeling for Makena (hydroxyprogesterone caproate). U.S. Food and Drug Administration.
- IQVIA. (2020). Pharmaceutical Market Data.
- U.S. Patent and Trademark Office. (2022). Patent Expirations.
- AMAG Pharmaceuticals. (2021). Makena Product Information.
- Congressional Research Service. (2022). Biologics, Biosimilars, and Patent Law.
[1] Food and Drug Administration. (2021). Labeling for Makena. https://www.fda.gov/media/91563/download
[2] IQVIA. (2020). U.S. pharmaceutical market data.
[3] U.S. Patent and Trademark Office. (2022). Patent database.
[4] AMAG Pharmaceuticals. (2021). Makena prescribing information.
[5] Congressional Research Service. (2022). Biologics, biosimilars, and patent law.
